1.0 OBJECTIVE
To lay down a standard procedure for receiving the samples in microbiology lab.
2.0 SCOPE
This Standard Operating Procedure is applicable to Microbiological section in Quality Control
Department.
3.0 RESPONSIBILITY
Microbiologist shall be responsible to follow the procedure mention in this SOP.
4.0 ACCOUNTABILITY
Department Head & QA Head shall be accountable for effective implementation and compliance of
this SOP.
5.0 ATTACHMENTS
Format for Water samples inward record – Attachment-I
Finished and In process samples inward record – Attachment-II
Raw material inward record – Attachment-III
Miscellaneous samples inward record – Attachment-IV
6.0 PROCEDURE
6.1 Water samples
6.1.1 Microbiology personnel shall perform the sampling and collection of water from sampling points as
per SOP no. SOP/ML/012.
6.1.2 After collection of water samples microbiology personnel shall allot the AR. No. in the respective
Format as per attachment-I
6.1.3 Samples shall be transferred to the respective testing area.
6.2 Finish and In process samples
6.2.1 The finished and the In process samples comes into the quality control lab through quality
assurance department shall be received by microbiology personnel and allotted AR. No. is entered
in the format as per attachment-II.
6.3 Raw material
6.3.1 The chemical/microbiology personnel shall perform the sampling of raw material. The sample shall
be received by microbiology personnel and the allotted AR. No. is entered in the respective register
as per attachment-III..
6.4 Miscellaneous samples
6.4.1 The miscellaneous samples such as validation samples hold time samples and primary packaging
samples are received in microbiology lab through quality assurance department and sampled by the
microbiologist.
5.4.2 After receiving the sample the entry is done in the miscellaneous inward record in format as per
attachment-IV and AR. No. is allotted and the samples are distributed for testing.
7.0 REFERENCES
In-house
8.0 ABBREVIATIONS
SOP: Standard operating procedure
- No. : Analytical report number
QA : Quality Assurance
QC: Quality Control
9.0 DISTRIBUTION LIST
Quality Assurance Department
Quality Control Department
10.0 HISTORY OF REVISION
| Version Number | Effective Date | Reason for Revision |
